Herniated Disc
Conditions
Keywords
contained lumbar herniated disc, nucleoplasty, percutaneous decompression, Dekompressor, intervertebral electrothermal disc decompression, IDET
Brief summary
The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.
Detailed description
Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back pain. Over the last decade, there is a tendency to shift from surgical treatment of the intervertebral disc including laminectomy/discectomy to an excess of nonoperative management. Three techniques introduced recently are used as minimally invasive treatments for decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation® radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter disc decompression uses heat from a resistive coil positioned in the area of disc herniation while Dekompressor® uses volume reduction to decrease an intradiscal pressure. This is a comparison study which investigates if intervertebral electrothermal disc decompression produces better pain relief measured on VAS scale, improvement in functional capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled study. Patients will be randomized into four treatment groups in equal numbers. The first group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc decompression, the third will receive thermal treatment using decompression catheter (Achutherm TM) and the forth will be the control group. The control group will be treated conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy. Patients will be followed and assessed at one, three, six, nine and twelve months following the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and return to work evaluation.
Interventions
PROCEDURENucleoplasty
PROCEDUREPercutaneous decompression
PROCEDUREIntervertebral electrothermal disc decompression (IDET)
BEHAVIORALConservative treatment
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months * Leg pain must be greater than back pain * Contained disc herniation as evidenced by MRI * No evidence of psychological issues by exam or history
Exclusion criteria
* A score of greater than 10 on Beck Depression Inventory (BDI) * Patients with pending workers compensation claim or litigation * Pregnancy * Tumor * Systemic infection or localized infection at the anticipated entry needle site * Traumatic spinal fracture * History of coagulopathy * Unexplained bleeding * Progressive neurological deficits * History of opioid abuse or patients currently on long acting opioids * Patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months | baseline 1, 3, 6, 9, 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry results | baseline 1, 3, 6, 9, 12 months | Disability Index |
| Quality of Life SF-36 | baseline 1, 3, 6, 9, 12 months | SF-36 score at baseline 1, 3, 6, 9, 12 months |
| Return to work evaluation | 1 month | Return to work evaluation |
| Depression score | BASELINE | Beck Depression Inventory score at pre-treatment visit |
| Opioid use | 1, 3, 6, 9, 12 months | Opioid use |
Outcome results
None listed